eDiscovery Process

In earlier posts (here, and here) , I described AIIM’s Certified Information Professional certification.

Well I’ve been working my way through the training material, and got to the section on eDiscovery . Steve Weissman does a great job of describing the Electronic Discovery Reference Model (EDRM).

Electronic Discovery Reference Model.

EDRM-Chart_v3

 

Identification

The Identify Solution performs a full index of all data in place prior to collection, creating an auditable “data topology map” of active ESI, files, and email located on network servers, email servers, content management systems, storage systems, and PCs. Data topology maps are highly customizable to meet specific scan criteria, and they provide an automated and recurring way to identify ESI across unstructured sources, tag it, and apply business rules for eDiscovery.

 Preservation

The eDI Preservation Solution process allows documents that meet the preservation criteria to be searched in place, and then moved without the need for specialized collection tools. This process also authenticates collection and preservation by maintaining an audit log of the collection and by creating a hash value before and after collection. In addition, access control lists (ACLs) and security identifiers (SIDs) are preserved, proving file ownership as tracked by the file system.

 Collection

In addition to traditional collection technology and methods, eDI has technology that provides on a solution that crawls and collects data on network servers, storage systems and personal computers, all without disrupting end users. No agent software has to be installed on PCs, and the solution is entirely transparent to users.

Culling and Processing

The collected documents, or the corpus, will need to be culled, based on the scope of the litigation and the information needing to be reviewed. Date range, document type, duplicate information, and keywords are a few of the methods used to reduce the corpus. At this stage the goal is to reduce the corpus down to a manageable size before human effort is expended.

The next step is to prepare the documents for a database review. Different tools have varying capabilities. Nor are cases identical, or the information required for them. As a result, processing will vary. In some cases, processing may occur all at one time and everything will be converted into its final production form of TIFF images. In other cases, the corpus will only go through light processing to make the native files suitable for review.

Analysis

eDI provides a variety of cutting edge technologies that enable data analysis at virtually every stage of the EDRM model. These processes of evaluating a collection enable a rapid understanding of data that can enable the determination relevant summary information, such as key topics of the case, important people, specific vocabulary and jargon, and important individual documents early in each phase of ESI processing.

When a defensible workflow is combined with the eDI toolset, then user can be presented with information essential to making better and more informed decisions about out to target and process the ESI collection.

Review

There are a number of ways and tools that can be used to review the corpus. Paper, TIFF, database, and native documents are all examples of forms in which a review can take place. Over a given case, the process you use will likely incorporate all of these forms. Information needs to be portable, and in most cases that will require good planning and consensus with all involved.

The goal of this step is to reduce the corpus down to the set of documents you are going to produce and use in the case. Without proper planning, this step can be lengthy and costly. There are a number of strategies that can be used to reduce both.

Production

With the corpus down to relevant documents, it is now time to produce them to the opposing counsel. Typically both sides have agreed upon their exchange methodologies during the discovery planning process. These include paper, TIFF or PDF images with a database of metadata. In increasingly more cases, parties are exchanging data in native form or in native with metadata extracted.

=========================================

Paper Discovery Reference Model (PDRM)

The link here leads to an amusing article that maintains that the Electronic Discovery Reference Model is actually nothing new…

 

Total Regulatory Solution – a “complete” offering from CSC – Webinar 1

The other day I received an invitation from CSC to attend a series of three webinars on their “Total Regulatory Solution” offering.

The “Total Regulatory Solution” consists of three “components”:

  • Software
  • As a service offering
  • Business Process Outsourcing.

Having described CSC’s plans for this earlier (In Part 1, and Part 2 of the FirstDoc User Group posts), I was curious to see what CSC would cover.

Webinar 1

The first webinar was entitled “Flicking the Switch: Integration Drives Greater Regulatory Efficiency” and was presented by Jennifer Webstrom. 

Here are some key points from the webinar:

  • CSC’s was primarily driven by technology (that is – what is required to make sure that their products would run on the latest, and upcoming, technology platforms).
    Approximately 18 months ago they decided to change to focus more on how they can solve business problems that their customers were having.
  • They want to be the go-to company for regulatory submissions.
    Or, to quote their mission statement, they want to…

Provide end to end business solutions for processes involving the creation, review, approval, consumption & exchange of regulated and mission critical documents and content within a Life Sciences organization

  • With the recent acquisition of ISI, CSC offer tools that allow for end-to-end regulatory information management process. These include:
    • Tracker  
    • Assembly Planner
    • FirstDoc or FirstPoint
    • eCDTXPress
    • Publisher
    • Viewer
  • These applications are, currently, disparate applications, but CSC are working to integrate these tools so that they share a common data model, have the same interface, and (ultimately) will be “aware” of the other tools, in the sense that operations in one tool trigger certain “pre-emptive” actions in the other tools.
  • The integration roadmap includes the following:
    • ensure that Publisher, eCDTXpress, FirstDoc, and Viewer work together
    • release of Tracker – integrated with Viewer
    • release of Assembly Planner – integrated with Tracker

Strategy Analysis

This had to happen. Providing an application, or a collection applications, that allow users to perform specific tasks is one thing, but to have a truly integrated suite of tools that can work together, is another. Users do not want to have to “think” about what they are doing. They just want to be able to complete a task, in the most efficient way they can, without having to consider the different interfaces that they need to work with, or the different processes that they have to follow for each application they use.

By changing their focus from one of technology to one that is more on the business challenges that pharmaceuticals companies face, means that CSC can streamline the whole regulatory submission process so that there is as little “pain” as possible.

And, naturally, if they can achieve this, they do help to position themselves in the market as the “one-stop shop” that they want to be.

The other webinars

As mentioned above, there are three webinars in which CSC are describing their new “Total Regulatory Solution”. The other webinars are:

  • Data in the Sky: Finding Flexible Solutions in the Cloud
  • Clearing the Path to Innovation: Exploring Total Regulatory Outsourcing

I plan to write posts on these as well.

Reference sites

A couple of reasons for me to travel to Switzerland – ARMA & Chris Walker

On Monday morning, I’m heading to Switzerland.

The Swiss Chapter of ARMA, is having their inaugural meeting, in Basel, and a fellow tweeter of mine, Christian Walker, will be giving the key note speech there.

Because I’m “in the neighborhood”, (sort of), he suggested I come along to it.

I’m really excited…for two reasons.

This is going to be the ever first meeting of the ARMA’s Swiss Chapter!
I’m really pleased that I have the opportunity to be present during this.

The second reason is that I really, really enjoy the chance to meet some of the really smart ECM people that I tweet with. Christian is a senior consultant at Oracle in Edmonton, as well as an “expert blogger” for AIIM. I’ve be connected to Christian for over a year now, and have been involved in many Twitter discussions with him (and others) on subjects ranging from ECM through to “toilet paper” (long story…maybe I’ll cover this in a separate blog).   Needless to say – I am looking forward to meeting him in person.

(I had an excellent opportunity recently to meet up with another fellow Tweeter, Laurence Hart, in Paris, a few months ago (I was invited as a guest blogger to Nuxeoworld, where Laurence was giving the keynote speech.)
Because of various circumstances, I couldn’t make it – something I still regret).

Needless to say – I’ll be taking notes during the sessions (especially the keynote speech), and plan to write a blog post once I get back.

Related Links

FirstDoc, FirstPoint, NextDocs – a “rough notes” comparison

21 CFR 11 Compliance evaluationA reader has recently asked if I had any information on the differences between FirstDoc, FirstPoint and NextDocs.

To do a full feature-for-feature comparison of all the solutions is not something that I can easily do.  However I have been able to get my hands on some great documentation, and can put together a “rough notes” comparison of the three solutions with regards to the core system, and how each solution complies with 21 CFR Part 11.

Note – this is version 2 of this post. After publishing the initial version, one of the vendors was able to provide me with a later version of their compliance statements. The table below has been updated as well as the Comparison PDF that can be downloaded. This is marked as Version 2. The link in the references still links back to the original compliance statement.

Important Note 1:

The FDA regulation, 21 CFR Part 11, is often update and modified. The documentation that I was able to find from CSC, and NextDocs appears to have been created at different times. As a result – I found some “discrepancies” between them. Sometimes the wording in the material I had, didn’t match the current version of the regulations. However, the “intent” is still the same.

Important Note 2:

I do not claim to be an expert in 21 CFR 11. Nor do I claim to be an expert in each of the different platforms/applications described in this post. I will list my references at the bottom this, but I make 2 recommendations:

  1. 21 CFR Part 11 can be interpreted in slightly different ways. Discuss with your internal QAV people what the expectations are.
  2. Make contact with the vendors in question to really determine whether their application fits your requirements.


21 CFR Part 11

To get read what is specifically contained in 21 CFR Part 11, click on this link. This will open the FDA’s “CFR – Code of Federal Regulations Title 21” site.

Product Comparison

Below I have listed each vendors response to each of the regulations outlined in 21 CFR 11.

This was compiled using information that can be found on the Internet. (I include reference links at the bottom of this post, as well as in the PDF.)

However, as mentioned – this is intended merely as a guideline. I encourage you to contact each of the vendors directly to get an updated statements of compliance, as well as information on server configuration/sizing & prerequisite software.

(Note to vendors – if you feel that there are errors, please let me know in the comments, and I will make the necessary corrections).

You can also click HERE to download a PDF version.

FirstDoc, SPX, FirstPoint & NextDocs

Subpart B – Electronic Records
§ 11.10 CONTROLS FOR CLOSED SYSTEMS

21 CRFR 11 Requirement FirstDoc FirstPoint NextDocs
(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. FirstDocis developedin accordance with the CSC LSQMSadvantage™, an ISO 9001:2000 certified Quality Management System.QMSadvantage and FirstDochave been audited by many pharmaceutical clients. As part of a formal vendor audit, CSC canprovide evidence that FirstDoc is developed and testedin accordance with QMSadvantage.FirstDoc has been validated by many clients. CSC offers a validation package (consisting of validation plan, traceability matrix, and IQ/OQ/PQ protocol templates and OQ protocols) with each release of the FDRD, FDQ&M, and FDTMF products. FirstPoint is developed in accordance with the CSC LS QMSadvantage™, an ISO 9001:2000 certified Quality Management System. QMSadvantage™ has been audited by many pharmaceutical clients. As part of a formal vendor audit, CSC can provide evidence that FirstPoint is developed and tested in accordance with QMSadvantage™.FirstPoint is “validation ready” for its clients upon completion of installation and configuration. Full IQ, OQ validation scripts, a PQ template and supporting services available from CSC for interested clients. Validation is ultimatelythe responsibility of the client as validation can only be performed in the environment in which the softwarewill be used, and against specifications defined by system users.NextDocs offers a validation toolkit to streamline the validation process.The toolkit includes a sample validation master plan and traceability matrix, ready-to-run scripts for IQ and OQ, summary report templates, and sample PQ scripts.NextDocs also has standard professional services packages that include assistance with validation planning, PQ script preparation, and managing PQ script execution and documentation activities.
(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records. Documentum will satisfy this requirement in conjunction with a company’s records management policy. Features of Documentum that support generation of accurate and complete copies in human readable form include the generation of PDF renditions and the ability to view and print these renditions in accordance with a system’s defined security rules.Additional support for this requirement is provided by FirstDoc’s automatic PDF rendition generation feature. Each time the content of a document is modified and the modifications checked in, FirstDoc generates a PDF rendition from an approved rendition generation station if the format supports transformation to PDF. Automatic transformation to PDF ensures that all documents will be readable in the foreseeable future. FirstPoint satisfies thisrequirement by managingaccurate and complete copies of files in human readable form with the tight integration with the Microsoft Office Suite of products andthe generation of PDF renditions and the system generated and maintained metadata. The system also provides human readable audit trails and reports. The ability to view and print these files and associated metadatais managedin accordance with a system’s defined security rules.All relevant recordsare maintained in their native file format within a robust MS SQL database and MS SharePoint environment. FirstPoint generates a PDF rendition from an approved rendition generation station, if the format supports transformation to PDF. Automatic transformation to PDF ensures that all documents will be readable into the foreseeable future. Actual generation of records is a client responsibility. NextDocs facilitates generating copies of records by:

  • Viewing records in native electronic format with any computer running one of several supported browsers.
  • Allowing records to be exported by dragging and dropping to any desired file system location
  • Providing sophisticated controlled, uncontrolled and clean copy printing capabilities

 

(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.
  • Documents may be retained in the system throughout their retention period, or an archiving process developed to store them outside the system. Documentum’s built-in archiving capability can be used to migrate content offline while maintaining metadata in the docbase.
  • FirstDoc uses Documentum’s robust security, which limits the capability for modifying and deleting records to designated users. FirstDoc automatically applies security to Approved documents that prevents them from being deleted or modified.
  • The FirstDoc product also includes an optional Records Management module which implements retention policies and allows deletion of records which have reached the end of their retention periods in accordance with a standard process.
Documentsmay be retained in the system throughout their retention periodthrough the use of a built-inlifecycle management system.FirstPoint applies robust security across the entirelifecycle, which prevents and limits approved or historical records from being deleted or modified except by specifically designated users. A document restore feature is available to the system administrator that allows for the retrieval of deleted records.All FirstPoint content is retained for retrieval until some business rule criteria has been meet to trigger the destruction. Records retention fun includes the ability to purge specific cycles of minor or major versions at the Library Level and purge working comments and draft comments after a specified retention period.  NextDocs systems automatically “lock down” official versions of documents so that they cannot be deleted or modified without following system configurable change control procedures.
(d) Limiting system access to authorized individuals.
  • The underlying Documentum application implements a secure username and encrypted password (generally the network password) to limit access to authorized individuals.
  • FirstDoc augments Documentum security by providing automatic application of a client’s defined security scheme. Users cannot modify security outside of the rules defined by the client.
  • FirstPoint provides a secure username and encrypted password for all users in addition to the network access/password system.
  • FirstPoint augments the SharePoint basic Library level security by allowing permission sets to be applied based on any metadata in the system. This allows for content to have a more granular security model based on role, site, project, product etc, and allows for confidential documents to have a restricted access permission set.
  • FirstPoint also provides application level rights to system and business administration function such as setting up workflow and other business rules templates.
In general, an SOP is needed to define the roles and responsibilities for the administration and maintenance of the groups and users for the system and/or network permissions. Access to NextDocscan be controlled by configuration. Securitycan be configured to use Active Directory or Active Directory Lightweight Directory Services accounts or accounts created within SharePoint. Internal users with on-premises deploymentscan access NextDocs applications through single sign-on without requiringadditional system login unless performing a signature related action in the system.Alternatively, if a client’s Part 11 interpretation requires explicit sign-onto access the system, single sign-oncan be disabled. Internal users with hosted deployments access NextDocs applications by providing a user name and password.External users access NextDocs applications by providing a user name and password. Depending on a client’s security set-up, Virtual Private Network (VPN) access may be required as well.
(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.
  • FirstDoc uses the Documentum audit trail capability augmented by audit trail entries produced for custom FirstDoc events. Example events include checkin, save, destroy, status change and user acknowledgements, such as review and approval outcome — including electronic signature. Since the audit trail must be maintained for the life of the record, Documentum’s Purge Audit Trail capability should not be used unless the audit trail has been migrated offline as controlled by a client’s SOP. Note: This assumes that the approved record is the electronic record. Audit trail entries for draft, minor versions of records can be deleted using the FirstDoc purge minor version functionality if the clients’ policies dictate.
  • FirstDoc provides thecapability for authorized users to change document metadata on approved records. In this case, an audit trail entry captures the previously recorded values so they are not obscured.
    • SharePoint records all events that occur on documents, the time and date of the and the username of individual (or system account) performing the action.
    • FirstPoint also provides a preconfigured, system generated audit trail report for each document that records the date/time of all critical events that occur during the entire of the document or record from creation, review and approval.
      The username of the individual (or system account) who invoked each action during the history of the document is also shown in the audit trail report.
      Information pertaining to previous document will continue to be displayed in the audit trail report, even as new versions of the document are created.
    • The audit trail report is presented as a single viewable and printable file.
    • The audit trail report is systematically generated, and cannot be overwritten or otherwise modified by any user.
NextDocs records:

  • Record modification events including check-in and check-out.
  • Move, copy, delete and undelete events.
  • Electronic/Digital Signature events.
  • Lifecycle promotions and demotions
  • Workflow events
  • Permission changes
  • Record viewing (configurable).

Audit trail entries include event, user name and server-based time/date stamp. Local time/date stamps can also be configured if desired.

Audit trail records are retained indefinitely unless manually purged from the system.

NextDocs also provides access to and copying of the audit trail. The audit trail can be saved to Excel with a single click for advanced sorting, filtering and analysis.

(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. These checksare implemented within a number of system functions. They include client-defined control over:

  1. Enforcing the use of approved templates only in creating documents
  2. Limiting property values to predefined dictionary lists wherever possible
  3. Requiring entry of mandatory attributes
  4. Enforcing storage in a pre-defined hierarchy (cabinet/folder structure)
  5. Enforcing a defined document lifecycle and approval process
  6. Ensuring that all required electronic signatures are obtained (if electronic signatures are used)
These checks areimplemented within a number of system functions. They include client control over:

  • The use of approved templates in creating documents/records.
  • Predefined metadata dictionary lists which structure dependent valid choices.
  • Enforcement of mandatory metadata fields where required.
  • Enforcing a defined document lifecycle requiring a specific, defined review and approval process via document workflow
  • Enforcing the review and approval of the PDF rendition of the document, since that is generally considered to be the approved electronic record
  • Ensuring that all required electronic signatures or electronic approvals are obtained using systematic participant selection and voting rules.

 

These checksare implemented ina number of areas. Some examples include:

  • Ensuring that documents follow a defined lifecycle
  • Ensuring that workflows are used when needed to move a document through its lifecycle
  • Ensuring that documents are properly set up to display digital signatures before they can be signed
  • Ensuring that all required signatures are collected before a document is approved
  • Ensuring that documents meet requirements such as having a valid PDF rendition before becoming approved or effective
  • Ensuring that all required metadata is entered for a document
  • Enforcing the use of approved templates for authoring
  • Limiting pick lists to appropriate values when creating or modifying document properties
(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. These checksare implemented within a number of system functions. They include client-defined control over authorization for:

  • Document creation
  • Document access (delete, write, read, etc.) (via ACL security)
  • Changing status
  • Initiating and participating in the review and approval process
  • Signing documents (if electronic signatures are used)
  • Establishing document relations including change request relationships
  • Performing various types of business administration functions including dictionary maintenance, training record control, etc.
A series of authority checksare implemented within system functions. They include the following client defined controls:

  • Network access with unique ID and password controlled at the operating system level.
  • The SharePoint permission model controls document security at the Library (a collection of documents) and for draft versus approved documents.
  • FirstPoint enhances this security model which allows additional security layers to be implemented based on document metadata. This is useful for documents required restricted, confidential controls.
  • Documents that are part of a workflow process receive enhanced security in that only those selected participants have access to the in progress document.
  • System configuration, maintenance and other types of business administration functions are accessed only by those individuals with specific access rights.

 

These checksare implemented ina number of areas. Some examples include limiting the following to authorized users:

  • Modifying a document’s content or properties
  • Initiating or participating in workflows
  • Applying digital/electronic signatures
  • Modifying system configurations
  • Generating controlled or uncontrolled copy prints
  • Modifying essential information, such as study investigators
  • Approving requests for system access
(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction. This requirement in general does not apply to FirstDoc since the system does not have any functionality where information is valid only when entered from specific terminals. If a specific client has this requirement, CSC will address the requirement for that client. This requirement in general does FirstPoint since the system does not have any functionality where information is valid only when entered only from specific terminals. If a specific client has this requirement, CSC will address the requirement for that client. This requirement does not apply to NextDocs since the system does not have any functionality where information is valid only when entered from specific terminals.
(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.
  • CSC maintains resumes and training records on all team members.
  • CSC provides training to key client team members including business users, business administrators, and system administrators.
  • Upon request, CSC can provide developer training to non-CSC developers employed by the client.
  • CSC maintains resumes and training records for all its team members.
  • CSC will also help generate training records to track any training it provides to the client’s personnel.
NextDocs maintains resumes and training records s to provide evidence that our employees who develop and deploy our software are trained and qualified to do so.NextDocs also provides client-specific training documentation to help our clients comply with this requirement. We also offer end user training, train-the-trainer training and administrator training.
(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification. N/A This requirement is not applicable at a system level but requires a procedure to be implemented by the client. Client responsibility
(k) Use ofappropriate controls over systems documentation including:(1) Adequate controls overthe distribution of, access to, and use of documentation for system operation and maintenance.(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation. Electronic audit trail for the appropriate document types must be enabled if documentation is maintained in electronic format.
  • CSC will provide the client copies or access to system documentation corresponding to the licensing agreement and version of the product.
  • CSC maintains a strict version and change control methodology for its product, product related documentation and training materials.

 

NextDocs’s documentationis maintained in our configuration management system and available for review during audits.However, ultimately it is the client’s responsibility to control system documentation in their environment.NextDocs’ release notes describe the names and versions of documentation that apply to each product release. In addition, each client receives documentation specific to their NextDocs implementation.
§ 11.30 Controls for Open Systems. Same as § 11.10 plus document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.
  • If the system is judged to be an open system, it would require encryption and digital signature standards. This is not part of FirstDoc and can be contracted as an option if needed.
CSC believes the FirstPoint products are a closed system so section 11.30 is not applicable. NextDocs systems that are hosted may be considered open based on the specific circumstances and the client’s 21 CFR Part 11 interpretation. The use of digital signature is available in all NextDocs products to fulfill the additional requirements imposed on open systems.

Subpart B – Electronic Records
§ 11.70 SIGNATURE/RECORD LINKING

21 CFR 11 Regulation FirstDoc FirstPoint NextDocs
Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.
  • Signature information is stored as document properties.
  • Signature information is also displayed as non-editable properties on the Properties screen.
  • • Signaturesare removed when a documentis edited, copied, or otherwise modified.
    • Electronic signatures can only be applied to a document\record through the administrator-configured workflow process and the proper execution of approval rules.
    • The signature page is fused to the PDF rendition of the document and cannot be excised from the document.
    • Signature information is also retained as non-editable data in the database and is displayed in the document’s audit trail report.
    • When a document is revised or copied, the signature page is removed from the new version of the document.
Signatures are bound directly to a specific version of a document.NextDocs digital signaturesare based on Public Key Infrastructure (PKI) and are a result of a cryptographic operation that guarantees signer authenticity, data integrity and non-repudiation of signed documents. The digital signature cannot be copied, tampered or altered.Digital signatures appearing in a document automatically appear as invalid when the document changes in any way.During change control the signature is removed for the draft version in anticipation of future approval and signing.

Subpart C – Electronic Signatures
§ 11.100 General requirements.

21 CFR 11 Regulation FirstDoc FirstPoint NextDocs
(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
  • The client will need an SOP on establishing and maintaining user profiles as applied to the assigning of a unique ID code/password combination to only one individual and maintaining a list of user profile information in perpetuity.
  • Documentum can assist with this via the ability to disable (rather than delete) users who are removed from the system. By leaving the users in the system, but disabling them, re-use of their user IDs will not be possible.
  • The network operating system ensures a unique userid which is used to execute the electronic signature.
    FirstPoint allows the administrator to lockout or disable accounts, as well as delete users from the system.
Since NextDocs is generally implemented such that user credentialsare supplied via Active Directory (or Active Directory Lightweight Directory Services), complianceis built in.Active Directory willensure that a user name cannot be re-used within a given domain, andprovide the ability to disable (rather thandelete) users whoare removed from the system. By maintaining a record ofprevious users, reuse of user IDswill not be possible.NextDocs signatures authenticate the content of documents by attributing the signer to the signed document. Every signer is identified by an issued certificate (or by that of an external trusted entity). This identification is based on the fact that the user is a recognized employee in the organization.
(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. The client will need SOPs on establishing and maintaining user profiles as applied to the verification of a user identity. This requirement needs to be met with a client’s business processes. CSC can help establish work instructions or training procedures to assist with the on-boarding process Client Responsibility
(c) Persons using electronic signatures shall,prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997,are intendedto be the legally bindingequivalent of traditional handwritten signatures.

  1. The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.
  2. . Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer’s handwritten signature.

 

  • The client will need to submit a letter to the FDA certifying that they consider electronic signatures are the legally binding equivalent to handwritten signatures.
  • The client will need SOPs on establishing and maintaining user profiles showing that a given individual accepts that the electronic signature is the legally binding equivalent of handwritten signatures.
  • This requirement needs to be met with a client’s business processes.
Client Responsibility

Subpart C – Electronic Signatures
11.200 Electronic signature components and controls.

21 CFR 11 Regulation FirstDoc FirstPoint NextDocs
(a) Electronic signatures that are not based upon biometricsshall:(1) Employ at least two distinct identification components such as an identification code and password.(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.

(2) Be used only by their genuine owners; and

(3) Be administered and executed to ensure that attempted use of an individual’s electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.

NoteContact CSC directly for their comments on how FirstDoc meets this regulation.  FirstPoint incorporates the user’s network account and password for general access to the system, which is also used for electronic signature approval. FirstPoint requires the re-entry of both identification components (user ID and password) each time an electronic signature is executed.. Each time a signature is applied, both a user name and password are required.NextDocs supports a configurable automatic time-out during periods of system inactivity. This time-out will also end a user’s continuous and controlled access to the system.
  • (b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.
FirstDoc can support the use of biometric solutions through customizations. Customizations for biometrics are not in the scope of this document. FirstPoint can support the  use of biometric solutions through customizations. Customizations for biometrics are not in the scope of this document. NA – Biometrics are not used by NextDocs.

Subpart C – Electronic Signatures
§ 11.300 CONTROLS FOR IDENTIFICATION CODES/PASSWORDS
Persons who use electronic signatures based upon the use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include:

21 CFR 11 Regulation

FirstDoc

FirstPoint

NextDocs

(a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password.
  • Documentum and Unix/Windows Server will provide most of this functionality. See Item § 11.10 (a).
  • The client will need an SOP on establishing and maintaining user profiles.
  • The client’s network user authentication methodology provides this functionality.
See item § 11.100 (a).
(b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).
  • Both Trusted Unix and Windows Server can be used to require periodic aging of passwords.
  • The client will need an SOP on establishing and maintaining user profiles.
  • The client’s network user authentication and password encryption methodology provides this function
This is a client responsibility, generally achieved through settings in Active Directory. Windows and Active Directory infrastructure can enforce password policy for complexity and expiration. Windows integrated authentication and Basic authentication can leverage this automatically.
(c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls.
  • The client will need an SOP covering loss management for passwords.
  • If devices are used, the client must have an SOP covering loss management.
  • NA
NextDocs does not make use of tokens, cards, and other devices that bear or generate identification code or password information.Windows and Active Directory administrators can deactivate users, change users’ passwords, or require users to change passwords after issuing a temporary password. Windows integrated authentication and Basic authentication can leverage this automatically
(d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management.
  • Both Trusted Unix and Windows Server can be used to disable user accounts after a configurable number of unsuccessful attempts.
  • The client will need an SOP containing the procedure for reactivating accounts.
  • The client’s network user authentication methodology provides this functionality.
  • Windows can disable user accounts after a configurable number of unsuccessful attempt
This is a client responsibility, generally achieved through settings in Active Directory.The Microsoft Windows family of products can audit logon changes and failed attempts. Group policy can enforce account lockout policy to help to prevent brute force password guessing. Lockout policy is based on failed attempts for a time window and users can be locked out for specified times before they can attempt again (or not).
(e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner.
  • If such devices are used, the client must have such a policy in place.
  • NA
NextDocs does not make use of tokens, cards, and other devices that bear or generate identification code or password information.


Audit Trail Functionality

Audit Trails is an included feature in FirstDoc. Documentum has its own audit trail capabilities, with FirstDoc adding on to Documentum’s audit trail system. Table 3 discusses the Audit Trails functionality that FirstDoc provides in support of 21 CFR Part 11.

Subpart C – Electronic Signatures
§ 11.10(E),(K)(2) AUDIT TRAIL

21 CFR 11 Regulation FirstDoc FirstPoint NextDocs
(a) Use of secure, computergenerated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.
  • • FirstDoc uses the Documentum audit trail capability augmented by audit trail entries produced for custom FirstDoc events. Example events include check-in, save, destroy, status change and user acknowledgements, such as review and approval outcome — including electronic signature.
  • • Since the audit trail must be maintained for the life of the record, Documentum’s Purge Audit Trail capability should not be used unless the audit trail has been migrated offline as controlled by a client’s SOP. Note: This assumes that the approved record is the electronic record. Audit trail entries for draft, minor versions of records can be deleted using the FirstDoc purge minor version functionality if the clients’ policies dictate.
  • • FirstDoc provides the capability for authorized users to change document metadata on approved records. In this case, an audit trail entry captures the previously recorded values so they are not obscured.
(b) Use of appropriate controls over systems documentation including: 1. Adequate controls over the distribution of, access to and use of documentation for system operation and maintenance. 2. Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.
  • • Electronic audit trail for the appropriate document types must be enabled if documentation is maintained in electronic format.

References

AIIM’s Email Management Practitioner Course

e-mail messages

Recently, I was on business about an hour north of Chicago for two weeks. I was staying at a hotel, and this is always a great opportunity to get some study done. (I know – sounds boring, but there is only so much drinking and partying that one can partake of).

In 2009 I had paid for an AIIM Email Management Practitioner course. This is an online course, and had an expiry date. Unfortunately over the last two years, things have been pretty hectic, and I never got around to doing the course. But thanks to the great people at AIIM (especially Angela) I was able to get the course extended past its expiry date a few times.

I started the course with, I have to admit, low expectations.

However, I quickly found that the course was incredibly valuable.

As well as covering the basics regarding e-mail such as architecture and protocols, it went into governance, ways to capture e-mail (as well as the attachments), and classification,  as well as discussing the various regulatory requirements, and “discoverability”, etc. It looked at email from the Records perspective.  (You can read more about the content of the course here on the AIIM site)

What I really liked about this course is that it also discussed the challenges & pragmatics of email management (including the limitations). It raised points that I have never really considered.

And that is what I liked. I didn’t feel that I was learning dry details. The course presented things in a way that I found myself, during the middle of the presentations, thinking about how I could apply what I was learning to real-life situations (clients I have worked with, etc).

All in all – I am really happy with the course.

Useful links:

Why Managing E-mail MattersWhy Managing E-mail Matters

Predicting User Acceptance

I‘ve been asked to help a friend with the design of a portal. Not just any type of portal, but one that will provide an alternative to using the standard “thick client”.

So, I started thinking about what I can do to really “sell” the portal to the users. What will make them WANT to use it, instead of the client that they are already familiar with.

During my studies for the AIIM course (mentioned in earlier posts), I read about the TAM.

The TAM is short for “Technology Acceptance Model“, and is a model that proposes that application usage and adoption can be predicted based upon two factors. Here is what the basic TAM looks like:

TAM User acceptance Technology Acceptance Model Percieved Usefulness Ease

So let’s look at it closer:

Perceived Usefulness can be defined as “the degree of which a person believes that using a particular system would enhance his or her job performance“.

Perceived Ease of Use as “the degree of which a person believes that using a particular system would be free of effort“.

These, together, influence the attitude of a user to a system, which in turn determines behavioral intentions and leads to actual system use.

So – what did I think of this when I first saw it? I thought “Duh!! That’s obvious.”

But then,as I though about it more, I realized that it IS obvious – if a user thinks something is going to make their job easier, AND they think that it will be effortless (not having to learn a new system, etc), then, of course, they are more willing to use it.

Now, the title of this post is “Predicting User Acceptance”. Because this is a model, lots of different values can be matched to each of the parts of the model, so that the outcome gives a mathematical value for the user acceptance.  That’s definitely gives something measurable. There are, in fact, a couple of documented examples where the TAM has been used to predict intranet/portal usage. I want to go into these in a future post.

Till then, the simplicity of the TAM has helped crystallize, for me, the real essence of user acceptance:

  • “Will this make my job/life easier?”
  • “Does it require effort to use?”

Read my following related posts:

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